Key result
Ranolazine increased total exercise duration at trough levels by 34.5 seconds compared to placebo in patients with severe chronic angina on maximally-tolerated background therapy (P=0.045).
Why the study?
Does ranolazine improve exercise tolerance and reduce angina frequency in patients with severe chronic angina receiving maximally-tolerated background therapy?
RCT (n=258)
Does ranolazine improve exercise tolerance and reduce angina frequency in patients with severe chronic angina receiving maximally-tolerated background therapy?
Mean Difference: 34.5 (95% CI 0.8–68.1)
p-value: p=0.045
Ranolazine effectively improves exercise duration and reduces angina frequency even in patients already receiving maximally-tolerated doses of first-line anti-anginal therapies.
May support adjunctive use in refractory angina on maximal therapy; hypothesis-generating and requires randomized confirmation before practice change.
BACKGROUND: Ranolazine has been previously shown to improve exercise capacity and symptoms in patients with severe chronic angina treated with standard doses of beta-blockers and calcium-channel blockers, without a significant effect on heart rate or blood pressure. OBJECTIVE: The purpose of this study was to assess whether the benefit of ranolazine extends to the subgroup of angina patients treated with maximally-tolerated doses of beta-blockers or calcium blockers. METHODS AND RESULTS: In this post-hoc analysis, 258 patients from the Combination Assessment of Ranolazine In Stable Angina (CARISA) trial were considered as treated with maximally-tolerated doses of beta-blockers or calcium-channel blockers (systolic blood pressure (SBP) ≤ 100 mm Hg, and/or a resting heart rate ≤ 60 beats per minute, and/or an ECG PR interval ≥ 200 msec). Change from baseline in total exercise duration after 12 weeks compared to placebo were 34.5 (95% CI 0.8; 68.1) sec (p = 0.045) with ranolazine (750/1000 mg bid) at trough drug levels and 46.3 (13.5; 79.1) (p = 0.006) at peak drug levels. The number of angina attacks per week compared to baseline were reduced compared to placebo (-2.3 ± 0.3 vs -0.9 ± 0.6 (p < 0.001)). The effects of ranolazine 750 mg bid and 1000 mg bid were similar and the beneficial effects of ranolazine in this subgroup of maximally-treated patients were consistent with those not on maximally-tolerated doses of the background therapy. CONCLUSION: Ranolazine is effective for the symptomatic treatment of patients with stable angina on background therapy with maximally-tolerated doses of first line anti-anginal therapies.
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Sendón et al. (2012) conducted an RCT in severe chronic angina (n=258). Ranolazine vs. placebo was evaluated on Change from baseline in total exercise duration after 12 weeks at trough drug levels (MD 34.5, 95% CI 0.8-68.1, p=0.045). Ranolazine increased total exercise duration at trough levels by 34.5 seconds compared to placebo in patients with severe chronic angina on maximally-tolerated background therapy (P=0.045).
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